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U.S. Department of Health and Human Services

Safety

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Rapamune (sirolimus) tablets and oral solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2010

 

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • Hematological/Lymphatic – The concomitant use of Rapamune with a calcineurin inhibitor may increase the risk of calcineurin inhibitor induced HUS/TTP/TMA; pancytopenia, neutropenia

PATIENT COUNSELING INFORMATION

Skin Cancer Events
  • Patients should be told that exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor because of the increased risk for skin cancer.